Primary Device ID | 10810091040291 |
NIH Device Record Key | eb6f1464-b736-4e24-bca5-e79f60b30e56 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | IOPI® |
Version Model Number | Report Generator v 1.0 |
Catalog Number | 5-8101 |
Company DUNS | 828391396 |
Company Name | Iopi Medical LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | 425-549-0139 |
info@iopimedical.com | |
Phone | 425-549-0139 |
info@iopimedical.com | |
Phone | 425-549-0139 |
info@iopimedical.com | |
Phone | 425-549-0139 |
info@iopimedical.com | |
Phone | 425-549-0139 |
info@iopimedical.com | |
Phone | 425-549-0139 |
info@iopimedical.com | |
Phone | 425-549-0139 |
info@iopimedical.com | |
Phone | 425-549-0139 |
info@iopimedical.com | |
Phone | 425-549-0139 |
info@iopimedical.com | |
Phone | 425-549-0139 |
info@iopimedical.com | |
Phone | 425-549-0139 |
info@iopimedical.com | |
Phone | 425-549-0139 |
info@iopimedical.com | |
Phone | 425-549-0139 |
info@iopimedical.com | |
Phone | 425-549-0139 |
info@iopimedical.com | |
Phone | 425-549-0139 |
info@iopimedical.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10810091040284 [Primary] |
GS1 | 10810091040291 [Package] Contains: 10810091040284 Package: 5-8101_EN [1 Units] In Commercial Distribution |
GS1 | 10810091040581 [Package] Contains: 10810091040284 Package: 5-8101_ES [1 Units] In Commercial Distribution |
IKE | Transducer, Miniature Pressure |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-03-31 |
Device Publish Date | 2025-03-21 |
10810091040062 | IOPI® Report Generator software is an accessory approved for use with the IOPI® Model 3.1 (Pro |
10810091040024 | The IOPI® Trainer (Model 3.2) is used to increase the strength and endurance of the tongue and |
10810091040000 | The IOPI® Pro (Model 3.1) is used by medical professionals to measure, evaluate, and increase t |
10810091040291 | IOPI® Report Generator software is an accessory approved for use with the IOPI® Model 3.1 (Pro |
10810091040277 | The IOPI® Trainer (Model 3.2) is used to increase the strength and endurance of the tongue and |
10810091040253 | The IOPI® Pro (Model 3.1) is used by healthcare professionals to measure, evaluate, and increas |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() IOPI 77740419 3725288 Live/Registered |
IOPI Northwest Co. LLC 2009-05-19 |